Label: LEADER MEDICATED- miconazole nitrate powder
- NDC Code(s): 37205-653-18
- Packager: Cardinal Health Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated October 31, 2012
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- Active ingredient
- INDICATIONS & USAGE
for the cure of most athlete's foot, jock itch and ringwormClose
For external use only.
Do not use
on children under 2 years of age unless directed by a doctor
- Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away. Close
- clean and dry affected area
- apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
- supervise children in the use of this product
- for athlete's foot, pay special attention to spaces between toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
- for athlete's foot and ringworm, use daily for 4 weeks ; for jock itch, use daily for 2 weeks
- if condition persists, consult a doctor
- this product is not effective on scalp or nails
- Other infomation
Product settles during shipment. Package contains full net weight.Close
- Inactive ingredients
aldioxa, chloroxylenol, fragrance, imidurea, powdered cellulose, talc. Contains no starchClose
- Box Label
Leader Medicated Miconazole Nitrate 2% Powder SprayClose
- INGREDIENTS AND APPEARANCE
miconazole nitrate powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-653 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE 1.42 g in 71 g Inactive Ingredients Ingredient Name Strength ALDIOXA (UNII: 8T66I31YNK) CHLOROXYLENOL (UNII: 0F32U78V2Q) IMIDUREA (UNII: M629807ATL) POWDERED CELLULOSE (UNII: SMD1X3XO9M) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-653-18 71 g in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 10/31/2010 Labeler - Cardinal Health Inc. (097537435)